(25 days)
These guidewires are intended for use in percuttaneous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature.
The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them. This document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data from dedicated studies.
Here's why and what's typically missing:
- Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technological characteristics and intended use, not necessarily by conducting independent clinical trials or detailed performance studies with acceptance criteria.
- "Same as Predicate" Justification: The document explicitly states: "Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices." This implies that the performance is presumed to be similar to the predicate, and new performance data against specific acceptance criteria is not provided in this summary.
Therefore, I cannot populate the requested table or answer most of the questions based solely on the provided text.
However, I can extract what is present:
- Device: Hydrophilic Coated Vascular Guidewires
- Intended Use: "These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature."
- Predicate Devices: K982559, K021990, and K031916
Regarding the specific questions:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence based on technical characteristics and intended use being similar to predicate devices.
- Sample size used for the test set and the data provenance: Not applicable/Not provided. This type of information would be part of a dedicated performance study, which is not detailed here. The submission relies on equivalence to existing devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This relates to clinical or performance studies, which are not outlined.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a guidewire, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided. (Again, this is not an AI/algorithm-based device).
- How the ground truth for the training set was established: Not applicable/Not provided.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.